Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
- Registration Number
- NCT00820742
- Lead Sponsor
- Pfizer
- Brief Summary
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.
- Detailed Description
Open-label, non-comparative, non-interventional study
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Must have at least one eye which was diagnosed with neovascular degeneration
Exclusion Criteria
- Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Phase IV Post Marketing Surveillance Study Macugen Open-label, observational study
- Primary Outcome Measures
Name Time Method Incidence of adverse events and serious adverse events 12 months
- Secondary Outcome Measures
Name Time Method Mean change in visual acuity in the study eye at 6 months from baseline 6 months